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CompletedNCT04449601Updated Jun 29, 2020

Normotensive and Hypertensive Placental Abruptions

An observational study in Abruptio Placentae; Affecting Fetus or Newborn, sponsored by Hatice Akkaya. Completed. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-29.

Sponsored by Hatice Akkaya · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
115
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Placental abruption is a significant cause of both maternal morbidity and neonatal morbidity and mortality. Most abruptions accept to be related to a chronic placental disease process. Therefore, it is very important to understand these processes. To analyze maternal and neonatal effects of placental abruption(PA) through a novel classification in the presence of hypertension. Initial hemoglobin parameters were also compared to predict pregnancy outcomes in addition to hypertension.

Read the detailed description

Objective: We aimed to classify placental abruption according to hypertension status.

Methods: This retrospective cohort designed study was conducted on 115 pregnant women with placental abruption. The main parameters scanned and recorded from the hospital database and patient medical files. Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive). Maternal demographical and clinical characteristics (abdominal pain, vaginal bleeding) were recorded. APGAR scores below 5 at 1 and 5 min., fetal or neonatal death, admission and length of stay in Neonatal Intensive Care Unit(NICU) were also investigated and compared between the groups.

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Conditions studied

  • Abruptio Placentae; Affecting Fetus or Newborn

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Keywords

  • Abruptio placenta
  • complete blood count
  • hypertension
  • perinatal outcome.
  • mean platelet volume
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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Two groups were formed according to presence or absence of hypertension (53 hypertensive, 62 normotensive) who has placental abruption.

Inclusion criteria

  • spontaneous,
  • singleton pregnancies
  • above 25 weeks of gestations with positive fetal cardiac activity

Exclusion criteria

Exclusion Criteria:

  • multiple gestations,
  • presence of fetal or maternal infection,
  • chronic inflammatory diseases or connective tissue disorders
  • history of myocardial infarction,
  • thrombosis
  • history of steroid drug usage.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
115 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1 (with hypertension )

    Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).

    Other: clinical assesment

  • Group 2( without hypertension)

    Two groups were classified regarding of presence or absence of hypertension (53 hypertensive, 62 normotensive).

    Other: clinical assesment

Interventions

  • Otherclinical assesment

    Comparison of Hypertensive group and normotensive group

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What researchers measure

Primary outcomes

  1. blood pressure measurement

    mm Hg

    Time frame: 2 minute

Secondary outcomes

  1. hemogram parameters WBC(white blood cell) ,PLT(Platelet), MPV(mean platelet volume), HGB(hemoglobin), Neutrophil lymphocyte ratio..)

    complete blood test retrospective complete blood count analysis

    Time frame: first 1 hour

  2. maternal and newborn length, weight

    centimeters,kilogram

    Time frame: 5 minute

  3. APGAR score

    1st and 5th minute newborn assesment

    Time frame: 5 minute

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — The data belonging to participant only will be available to any researcher or editorial review board if needed.

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04449601
Lead sponsor
Hatice Akkaya
Responsible party
Hatice Akkaya (Associate Professor, Kayseri Education and Research Hospital) — Sponsor-investigator
First posted
Jun 29, 2020
Start date
Jan 1, 2016
Primary completion
Apr 30, 2017
Completion
Nov 30, 2017
Last update
Jun 29, 2020

Study contacts

Hatice Akkaya, Ass Prof
principal investigator · Kayseri Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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